Recall archive / FDA company announcement
Olympus: Single use ligating device — FDA announcement Dec 18, 2025
Published notice; closure not supplied
A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing.
Source date Dec 18, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Single use ligating device
- Reason
- PolyLoop device may fail to detach as expected and become anchored to patient anatomy
- Classification
- Not supplied
- Recalling firm
- Olympus Corporation
- Quantity
- Not supplied
- Agency-reported status
- Company recall announcement
- Source record identifier
- 8d1e98722e4d0091
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Not supplied |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Not supplied
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Fda listing date
- Dec 18, 2025
- Company announcement date
- Dec 5, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.